CompletedNCT02541383CassiopeiaUpdated Apr 13, 2025Results posted

A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma

A Phase 3 interventional study of Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) and Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab in Multiple Myeloma, sponsored by Intergroupe Francophone du Myelome. Completed at 107 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-13.

Sponsored by Intergroupe Francophone du Myelome · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,085
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib, Thalidomide and Dexamethasone will increase the stringent complete response rate after consolidation therapy and increase the progression free survival after daratumumab maintenance therapy in transplant eligible participants with previously untreated Multiple Myeloma.

Read the detailed description

This is a randomized, open-label (identity of assigned treatment will be known to participants and study staff), 2-arm (2 treatment groups), multicenter study of daratumumab in participants diagnosed with previously untreated Multiple Myeloma who are eligible for high dose chemotherapy and autologous stem cell transplantation (transplantation of own bone marrow). Participants will be randomized (assigned by chance) to one of 2 treatment groups to either receive daratumumab plus bortezomib, thalidomide and dexamethasone or bortezomib, thalidomide and dexamethasone for induction (before transplantation) and consolidation (after transplantation) treatment. All responders will then be re-randomized (assigned by chance) to one of 2 treatment groups to receive maintenance treatment with daratumumab only or observation (no treatment). The study will include a 28-Day Screening Phase, a Treatment Phase of 6 treatment cycles (each cycle is 4 weeks in duration for total period of 30 weeks), and a Follow up Phase of 2 years. The total duration for each participant in the study will be approximately 138 weeks. The end of the study will occur approximately 5 years after the last participant is randomized in the second phase of the study. Disease assessments will be performed every 4 weeks in the first phase of the study and then every 8 weeks in the second phase of the study. Safety will be monitored throughout the study.

Conditions studied

Multiple Myeloma

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Keywords

Untreated Multiple Myeloma
daratumumab

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Diagnosis of previously untreated multiple myeloma (MM)
Have a confirmed diagnosis and eligible for high dose chemotherapy and autologous stem cell transplantation, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1 or 2

Exclusion criteria

Exclusion Criteria:

previous treatment for Multiple Myeloma
Primary amyloidosis, Plasma Cell Leukemia or Smoldering Multiple Myeloma
Prior or concurrent exposure to systemic therapy or SCT (Stem Cell Transplantation) for any plasma cell dyscrasia, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment, or received an investigational drug or used an invasive investigational medical device within 4 weeks before Cycle 1, Day 1
history of malignancy (other than Multiple Myeloma) within 10 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
known chronic obstructive pulmonary disease (COPD) or moderate to severe asthma
any concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 1,085 participants (actual)

Study arms

Other
Arm A Part 1
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
Drug: Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
Experimental
Arm B Part 1
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab
Drug: Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab
No intervention
Arm A Part 2
Observation
Experimental
Arm B Part 2
daratumumab
Drug: Daratumumab

Interventions

DrugBortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation
Also known as: Arm A Part 1
DrugBortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab
Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation
Also known as: Arm B Part 1
DrugDaratumumab
Daratumumab 16mg/kg every 8 weeks for 2 years
Also known as: Arm B Part 2

What researchers measure

Primary outcomes

Post-Consolidation Stringent Complete Response (sCR) Rate
Post-consolidation sCR rate is defined as the percentage of ITT subjects who achieved or maintained sCR status within 30 days of Day 100 post Autologous Stem Cell Transplant (ASCT). The sCR status is assessed using the computerized algorithm according to IMWG response criteria, and must be achieved on or prior to start of subsequent therapies. Subjects must not die or progress by Day 100 post ASCT. According to the IMWG consensus recommendations for multiple myeloma treatment response criteria from 2006, the stringent complete response (sCR) was defined by a negative immunofixation on the serum and urine, and a disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow, plus normal free-light chain ratio and the absence of clonal bone marrow plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
Time frame: At day 100 post Autologous Stem Cell Transplant (ASCT), up to 114 days post ASCT
Progression Free Survival (PFS) Post Completion of Maintenance Therapy
Progression Free Survival (PFS) post completion of maintenance therapy is defined as the duration from the date of second randomization to either progressive disease (according to the IMWG criteria specified in the protocol), or death, whichever occurs first (=all these considered as events) at the completion of Maintenance therapy.
Time frame: From the date of second randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 35.4 months (cut-off for analysis was 26 months after the last rando 2 date).

Secondary outcomes

Progression Free Survival (PFS) From First Randomization up to the End of the Study
Progression Free Survival (PFS) is defined as the duration from the date of first randomization to either progressive disease (according to the IMWG criteria specified in the protocol), or death, whichever occurs first (=all these considered as events) at the end of the study
Time frame: From the date of first randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 80.1 months at the end of the study

Results

Posted Apr 13, 2025

Participant flow

Participant flow — Overall Study
Milestone	VTd Only	DVTd Only * Arm/Group Title: Characters Remaining: 91	VTd-OBS	VTd-DARA	DVTd-OBS	DVTd-DARA
Started	114	85	215	213	229	229
Completed	53	38	165	170	205	204
Not completed	61	47	50	43	24	25
Withdrew: Death	50	37	48	41	21	25
Withdrew: Lost to follow-up	5	3	1	1	3	0
Withdrew: Consent withdrawn	5	6	1	1	0	0
Withdrew: Sponsor's decision	1	1	0	0	0	0

Outcome measures

PrimaryPost-Consolidation Stringent Complete Response (sCR) Rate

Post-consolidation sCR rate is defined as the percentage of ITT subjects who achieved or maintained sCR status within 30 days of Day 100 post Autologous Stem Cell Transplant (ASCT). The sCR status is assessed using the computerized algorithm according to IMWG response criteria, and must be achieved on or prior to start of subsequent therapies. Subjects must not die or progress by Day 100 post ASCT. According to the IMWG consensus recommendations for multiple myeloma treatment response criteria from 2006, the stringent complete response (sCR) was defined by a negative immunofixation on the serum and urine, and a disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow, plus normal free-light chain ratio and the absence of clonal bone marrow plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.

Time frame:: At day 100 post Autologous Stem Cell Transplant (ASCT), up to 114 days post ASCT
Reported as:: Count of participants · Participants

Post-Consolidation Stringent Complete Response (sCR) Rate
Participants	Arm A Part 1	Arm B Part 1
Post-Consolidation Stringent Complete Response (sCR) Rate	110	157

Statistical analysis

Arm A Part 1 vs Arm B Part 1 · Cochran-Mantel-Haenszel · p = 0.0010 · Odds ratio (or): 1.6 · 95% CI 1.21 to 2.12

PrimaryProgression Free Survival (PFS) Post Completion of Maintenance Therapy

Progression Free Survival (PFS) post completion of maintenance therapy is defined as the duration from the date of second randomization to either progressive disease (according to the IMWG criteria specified in the protocol), or death, whichever occurs first (=all these considered as events) at the completion of Maintenance therapy.

Time frame:: From the date of second randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 35.4 months (cut-off for analysis was 26 months after the last rando 2 date).
Reported as:: Median · Months

Progression Free Survival (PFS) Post Completion of Maintenance Therapy
Months	Arm A Part 2	Arm B Part 2
Progression Free Survival (PFS) Post Completion of Maintenance Therapy	46.7 (40.0 to NA)	NA (NA to NA)

Statistical analysis

Arm A Part 2 vs Arm B Part 2 · Log Rank · p = <0.0001 · Hazard ratio (hr): 0.53 · 95% CI 0.42 to 0.68

SecondaryProgression Free Survival (PFS) From First Randomization up to the End of the Study

Progression Free Survival (PFS) is defined as the duration from the date of first randomization to either progressive disease (according to the IMWG criteria specified in the protocol), or death, whichever occurs first (=all these considered as events) at the end of the study

Time frame:: From the date of first randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 80.1 months at the end of the study
Reported as:: Median · Months

Progression Free Survival (PFS) From First Randomization up to the End of the Study
Months	Arm A - Part 1 up to End of Study	Arm B - Part 1 up to End of Study
Progression Free Survival (PFS) From First Randomization up to the End of the Study	52.8 (47.5 to 58.7)	83.7 (70.2 to NA)

Statistical analysis

Arm A - Part 1 up to End of Study vs Arm B - Part 1 up to End of Study · Log Rank · p = <0.0001 · Hazard ratio (hr): 0.61 · 95% CI 0.52 to 0.72

Adverse events

Collected over AEs that started during the treatment until 30 days after the last dose of study treatment, approximately 59 months, except for secondary malignancies and deaths followed until the end of the study.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
VTd - Part 1	139/542 (25.6%)	261/538 (48.5%)	529/538 (98.3%)
DVTd - Part 1	83/543 (15.3%)	264/536 (49.3%)	534/536 (99.6%)
VTd-OBS - Part 2	48/215 (22.3%)	35/215 (16.3%)	170/215 (79.1%)
VTd-DARA - Part 2	41/211 (19.4%)	58/211 (27.5%)	194/211 (91.9%)
DVTd-OBS - Part 2	21/229 (9.2%)	50/229 (21.8%)	198/229 (86.5%)
DVTd-DARA - Part 2	25/229 (10.9%)	43/229 (18.8%)	205/229 (89.5%)

Most frequent serious events

Showing 10 of 379

Most frequent serious events
Event	VTd - Part 1	DVTd - Part 1	VTd-OBS - Part 2	VTd-DARA - Part 2	DVTd-OBS - Part 2	DVTd-DARA - Part 2
NeutropeniaBlood and lymphatic system disorders	8/538	22/536	0/215	0/211	0/229	0/229
PyrexiaGeneral disorders	22/538	15/536	0/215	0/211	0/229	2/229
PneumoniaInfections and infestations	9/538	21/536	2/215	4/211	4/229	7/229
Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders	20/538	8/536	0/215	0/211	0/229	1/229
Febrile NeutropeniaBlood and lymphatic system disorders	16/538	12/536	0/215	1/211	0/229	0/229
Peripheral Sensory NeuropathyNervous system disorders	16/538	11/536	0/215	0/211	0/229	0/229
ThrombocytopeniaBlood and lymphatic system disorders	4/538	12/536	1/215	0/211	0/229	0/229
Febrile Bone Marrow AplasiaBlood and lymphatic system disorders	12/538	7/536	0/215	0/211	0/229	0/229
SepsisInfections and infestations	11/538	7/536	1/215	0/211	0/229	1/229
Lung DisorderRespiratory, thoracic and mediastinal disorders	6/538	10/536	0/215	0/211	0/229	0/229

Most frequent other events

Showing 10 of 61

Most frequent other events
Event	VTd - Part 1	DVTd - Part 1	VTd-OBS - Part 2	VTd-DARA - Part 2	DVTd-OBS - Part 2	DVTd-DARA - Part 2
Peripheral Sensory NeuropathyNervous system disorders	340/538	325/536	24/215	31/211	27/229	39/229
ConstipationGastrointestinal disorders	255/538	271/536	2/215	10/211	6/229	7/229
BronchitisInfections and infestations	79/538	107/536	71/215	77/211	63/229	93/229
AstheniaGeneral disorders	159/538	176/536	27/215	35/211	26/229	26/229
Oedema PeripheralGeneral disorders	154/538	166/536	8/215	9/211	9/229	13/229
NauseaGastrointestinal disorders	129/538	159/536	2/215	33/211	4/229	10/229
NeutropeniaBlood and lymphatic system disorders	83/538	149/536	6/215	7/211	4/229	5/229
PyrexiaGeneral disorders	104/538	133/536	7/215	20/211	17/229	18/229
ParaesthesiaNervous system disorders	114/538	127/536	4/215	21/211	10/229	15/229
ThrombocytopeniaBlood and lymphatic system disorders	72/538	109/536	4/215	7/211	4/229	10/229

Baseline characteristics

Age, Continuous
Age, Continuous(years)	VTd Only	DVTd Only	VTd-OBS	VTd-DARA	DVTd-OBS	DVTd-DARA	Total
Mean	57.7 ± 6.36	57.8 ± 7.5	56 ± 6.96	56.3 ± 7.38	56.8 ± 6.83	56.4 ± 6.79	56.6 ± 6.98

Sex: Female, Male
Sex: Female, Male(Participants)	VTd Only	DVTd Only	VTd-OBS	VTd-DARA	DVTd-OBS	DVTd-DARA	Total
Female	42	37	94	87	96	94	450
Male	72	48	121	126	133	135	635

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	VTd Only	DVTd Only	VTd-OBS	VTd-DARA	DVTd-OBS	DVTd-DARA	Total
Count of participants	—	—	—	—	—	—	0

Region of Enrollment
Region of Enrollment(participants)	VTd Only	DVTd Only	VTd-OBS	VTd-DARA	DVTd-OBS	DVTd-DARA	Total
BELGIUM	15	5	11	18	23	17	89
FRANCE	70	64	191	169	177	183	854
NETHERLANDS	29	16	13	26	29	29	142

Baseline ISS Stage
Baseline ISS Stage(participants)	VTd Only	DVTd Only	VTd-OBS	VTd-DARA	DVTd-OBS	DVTd-DARA	Total
I	47	25	88	93	83	96	432
II	52	41	96	85	118	96	488
III	15	19	31	35	28	37	165

Baseline Type of Myeloma
Baseline Type of Myeloma(participants)	VTd Only	DVTd Only	VTd-OBS	VTd-DARA	DVTd-OBS	DVTd-DARA	Total
Biclonal	1	2	10	8	5	5	31
IgA	15	14	46	43	36	37	191
IgD	3	1	3	7	2	2	18
IgG	79	54	126	128	159	138	684
IgM	0	0	1	1	0	1	3
Kappa	11	9	17	18	17	27	99
Lambda	3	5	10	7	8	17	50
Negative immunofixation	2	0	2	1	2	2	9

Time since initial diagnosis to randomization (months)
Time since initial diagnosis to randomization (months)(months)	VTd Only	DVTd Only	VTd-OBS	VTd-DARA	DVTd-OBS	DVTd-DARA	Total
Mean	1.6 ± 2.65	1.3 ± 0.96	1.2 ± 0.86	1.2 ± 0.87	1.2 ± 1.08	1.2 ± 0.95	1.2 ± 1.25

Presence of diffuse myeloma-related osteopenia
Presence of diffuse myeloma-related osteopenia(participants)	VTd Only	DVTd Only	VTd-OBS	VTd-DARA	DVTd-OBS	DVTd-DARA	Total
No	100	76	197	194	203	208	978
Yes	14	9	18	17	25	19	102
Missing	0	0	0	2	1	2	5

2 further baseline measures are reported on the registry.

Study locations

107 sites

BE-Antwerp-ZNA Stuivenberg
Antwerp, Belgium
AZ St Jan Brugge Oostende AV
Brugge, Belgium
Institut Jules Bordet
Bruxelles, Belgium
UCL Saint-Luc
Bruxelles, Belgium
UZ Brussel
Bruxelles, Belgium
GHDC
Charleroi, Belgium
UZ Gent
Gent, Belgium
CH Jolimont
La Louviere, Belgium
University Hospital Leuven
Leuven, Belgium
Domaine Universitaire du Sart Tilman
Liege, Belgium
AZ Delta
Roeselare, Belgium
AZ Turnhout
Turnhout, Belgium
UCL Mont-Godinne
Yvoir, Belgium
CHU Amiens Sud
AMIENS Cedex 1, France
CHRU-Hôpital du Bocage
ANGERS Cedex 1, France
Centre Hospitalier d'Argenteuil Victor Dupouy
Argenteuil, France
Centre Hospitalier H.Duffaut
AVIGNON Cedex 9, France
Centre hospitalier de la Côte Basque
Bayonne, France
Hôpital Jean Minjoz
BESANCON Cedex, France
Hôpital Avicenne
BOBIGNY Cedex, France
Polyclinique Bordeaux Nord Acquitaine
Bordeaux, France
Hôpital de Fleyriat
BOURG EN BRESSE Cedex, France
CHRU Brest - Hôpital A. Morvan
BREST Cedex, France
CHU Caen - Côte de Nacre
CAEN Cedex, France
Clinique du Parc
Castelnau-le-lez, France
CH René Dubos
Cergy-pontoise, France
Hôpital Privé Sévigné
Cesson-Sévigné, France
Centre Hospitalier William Morey
Chalon-sur-Saône, 71100, France
CH Chambéry
Chambery, France
Hôpital d'Instruction des Armées Percy
CLAMART Cedex, France
CHU d'Estaing
Clermont-ferrand, France
Centre Hospitalier Sud Francilien
CORBEIL-ESSONNES Cedex, France
CHU Henri Mondor
Creteil, France
CHRU Dijon - Hôpital des Enfants
Dijon, France
Centre Hospitalier Général
Dunkerque, France
CHRU Hôpital A. Michallon
GRENOBLE Cedex 9, France
CHD Vendée
LA ROCHE SUR YON Cedex 9, France
CHV André Mignot - Université de Versailles
Le Chesnay, France
CH de Chartres - Hôpital Louis Pasteur
Le Coudray, France
Centre Hospitalier
LE MANS Cedex, France
Clinique Victor Hugo
Le Mans, France
CHRU Hôpital Claude Huriez
LILLE Cedex, France
GH de l'Institut Catholique Saint Vincent
Lille, France
Centre Hospitalier Universitaire (CHU) de Limoges
Limoges, France
Hôpital du Scorff
Lorient, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmettes
MARSEILLE Cedex, France
CH Meaux
Meaux, France
Hôpital de Mercy (CHR Metz-Thionville)
METZ Cedex 1, France
Hopital Saint Eloi - CHU Montpellier
MONTPELLIER Cedex, France
Hôpital E. Muller
Mulhouse, France
CHRU Hôtel Dieu
Nantes Cedex 1, France
Centre Catherine de Sienne
Nantes, 44202, France
Clinique de l'Archet
NICE Cedex 3, France
CHU Carémeau
NIMES Cedex 9, France
CH La Source
Orleans Cedex 2, France
Hôpital Saint Louis
PARIS Cedex 10, France
CHU Hôpital Saint Antoine
PARIS Cedex 12, France
Hôpital Cochin
Paris, France
Hôpital Necker
Paris, France
Institut Curie
Paris, France
La Pitié
Paris, France
Centre Hospitalier de Perigueux
Perigueux, France
CH Saint Jean
Perpignan, France
CHRU - Hôpital du Haut Lévêque - Centre François Magendie
Pessac, France
Centre Hospitalier Lyon Sud
PIERRE-BENITE Cedex, France
CHU Poitiers - Pôle régional de Cancérologie
Poitiers, France
Ch Annecy Genevois
PRINGY Cedex, France
Hôpital Robert Debré
REIMS Cedex, France
CHRU Hôpital de Pontchaillou
RENNES Cedex 9, France
Centre Henri Becquerel
ROUEN Cedex 1, France
Institut de Cancérologie Lucien Neuwirth
Saint Priest-en-jarez, France
Centre Hospitalier
SAINT QUENTIN Cedex, France
Centre Hospitalier Yves Le Foll
Saint-brieuc, France
CHU Strasbourg
Strasbourg, France
Strasbourg Oncologie Médicale
Strasbourg, France
Pôle IUCT Oncopole CHU
TOULOUSE Cedex 9, France
CHRU Hôpital Bretonneau
TOURS Cedex, France
CHRU Hôpitaux de Brabois
VANDOEUVRE LES NANCY Cedex, France
CHBA
VANNES Cedex, France
MC Alkmaar
Alkmaar, Netherlands
Meander MC
Amersfoort, Netherlands
AMC
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
Vumc
Amsterdam, Netherlands
Ziekenhuis Rijnstate
Arnhem, Netherlands
Amphia Hospital Breda
Breda, Netherlands
RdGG
Delft, Netherlands
Haga zkh
Den Haag, 2545 CH, Netherlands
Deventer zkh
Deventer, Netherlands
Albert Schweitzer zkh
Dordrecht, Netherlands
Maxima MC
Eindhoven, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
UMCG
Groningen, Netherlands
Atrium MC/Zuyderland MC
Heerlen, Netherlands
Tergooiziekenhuizen, location Hilversum
Hilversum, 1201 DA, Netherlands
Spaarne Gasthuis
Hoofddorp, Netherlands
MC Leeuwarden
Leeuwarden, Netherlands
LUMC
Leiden, Netherlands
MUMC
Maastricht, Netherlands

Showing the first 100 of 107 sites across 3 countries.

References and documents

Publications

Moreau P, Attal M, Hulin C, Arnulf B, Belhadj K, Benboubker L, Bene MC, Broijl A, Caillon H, Caillot D, Corre J, Delforge M, Dejoie T, Doyen C, Facon T, Sonntag C, Fontan J, Garderet L, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Lenain P, Macro M, Mathiot C, Orsini-Piocelle F, Perrot A, Stoppa AM, van de Donk NW, Wuilleme S, Zweegman S, Kolb B, Touzeau C, Roussel M, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Fermand JP, Escoffre-Barbe M, Eveillard JR, Garidi R, Ahmadi T, Zhuang S, Chiu C, Pei L, de Boer C, Smith E, Deraedt W, Kampfenkel T, Schecter J, Vermeulen J, Avet-Loiseau H, Sonneveld P. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. Lancet. 2019 Jul 6;394(10192):29-38. doi: 10.1016/S0140-6736(19)31240-1. Epub 2019 Jun 3. PubMed 31171419 ↗
Moreau P, Hulin C, Perrot A, Arnulf B, Belhadj K, Benboubker L, Bene MC, Zweegman S, Caillon H, Caillot D, Corre J, Delforge M, Dejoie T, Doyen C, Facon T, Sonntag C, Fontan J, Mohty M, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Macro M, Orsini-Piocelle F, Roussel M, Stoppa AM, van de Donk NWCJ, Wuilleme S, Broijl A, Touzeau C, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Offner F, Escoffre-Barbe M, Eveillard JR, Garidi R, Ahmadi T, Krevvata M, Zhang K, de Boer C, Vara S, Kampfenkel T, Vanquickelberghe V, Vermeulen J, Avet-Loiseau H, Sonneveld P. Maintenance with daratumumab or observation following treatment with bortezomib, thalidomide, and dexamethasone with or without daratumumab and autologous stem-cell transplant in patients with newly diagnosed multiple myeloma (CASSIOPEIA): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Oct;22(10):1378-1390. doi: 10.1016/S1470-2045(21)00428-9. Epub 2021 Sep 13. PubMed 34529931 ↗
Moreau P, Hulin C, Perrot A, Arnulf B, Belhadj K, Benboubker L, Zweegman S, Caillon H, Caillot D, Avet-Loiseau H, Delforge M, Dejoie T, Facon T, Sonntag C, Fontan J, Mohty M, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Macro M, Orsini-Piocelle F, Roussel M, Schiano de Colella JM, van de Donk NW, Wuilleme S, Broijl A, Touzeau C, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Offner F, Escoffre-Barbe M, Eveillard JR, Garidi R, Hua W, Wang J, Tuozzo A, de Boer C, Rowe M, Vanquickelberghe V, Carson R, Vermeulen J, Corre J, Sonneveld P; Intergroupe Francophone du Myelome, the Dutch-Belgian Cooperative Trial Group for Hematology Oncology and the CASSIOPEIA Investigators. Bortezomib, thalidomide, and dexamethasone with or without daratumumab and followed by daratumumab maintenance or observation in transplant-eligible newly diagnosed multiple myeloma: long-term follow-up of the CASSIOPEIA randomised controlled phase 3 trial. Lancet Oncol. 2024 Aug;25(8):1003-1014. doi: 10.1016/S1470-2045(24)00282-1. Epub 2024 Jun 15. PubMed 38889735 ↗
Alberge JB, Kraeber-Bodere F, Jamet B, Touzeau C, Caillon H, Wuilleme S, Bene MC, Kampfenkel T, Sonneveld P, van Duin M, Avet-Loiseau H, Corre J, Magrangeas F, Carlier T, Bodet-Milin C, Cherel M, Moreau P, Minvielle S, Bailly C. Molecular Signature of 18F-FDG PET Biomarkers in Newly Diagnosed Multiple Myeloma Patients: A Genome-Wide Transcriptome Analysis from the CASSIOPET Study. J Nucl Med. 2022 Jul;63(7):1008-1013. doi: 10.2967/jnumed.121.262884. Epub 2022 Jan 27. PubMed 35086897 ↗
Hulin C, Offner F, Moreau P, Roussel M, Belhadj K, Benboubker L, Caillot D, Facon T, Garderet L, Kuhnowski F, Stoppa AM, Kolb B, Tiab M, Jie KS, Westerman M, Lambert J, Pei L, Vanquickelberghe V, De Boer C, Vermeulen J, Kampfenkel T, Sonneveld P, Van de Donk NWCJ. Stem cell yield and transplantation in transplant-eligible newly diagnosed multiple myeloma patients receiving daratumumab + bortezomib/thalidomide/dexamethasone in the phase 3 CASSIOPEIA study. Haematologica. 2021 Aug 1;106(8):2257-2260. doi: 10.3324/haematol.2020.261842. No abstract available. PubMed 33657786 ↗
Roussel M, Moreau P, Hebraud B, Laribi K, Jaccard A, Dib M, Slama B, Dorvaux V, Royer B, Frenzel L, Zweegman S, Klein SK, Broijl A, Jie KS, Wang J, Vanquickelberghe V, de Boer C, Kampfenkel T, Gries KS, Fastenau J, Sonneveld P. Bortezomib, thalidomide, and dexamethasone with or without daratumumab for transplantation-eligible patients with newly diagnosed multiple myeloma (CASSIOPEIA): health-related quality of life outcomes of a randomised, open-label, phase 3 trial. Lancet Haematol. 2020 Dec;7(12):e874-e883. doi: 10.1016/S2352-3026(20)30356-2. PubMed 33242444 ↗

Study documents

Study protocol · Jan 14, 2021
Statistical analysis plan · Sep 16, 2020

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Key details

Study ID: NCT02541383
Lead sponsor: Intergroupe Francophone du Myelome
Collaborators: HOVON - Dutch Haemato-Oncology Association, Janssen Research & Development, LLC
Responsible party: Sponsor
First posted: Sep 4, 2015
Start date: Sep 2015
Primary completion: Aug 27, 2020
Completion: Sep 1, 2023
Results posted: Apr 13, 2025
Last update: Apr 13, 2025

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Philippe Moreau, Pr

principal investigator · CHU Nantes, France

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma

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